4 HOUR POWER HAND SANITIZER- benzalkonium chloride liquid 
Guide Energy Solutions LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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4 Hour Power Hand Sanitizer

Drug Facts

Active ingredient[s]

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use[s]

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

FOR EXTERNAL USE ONLY. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on your palm to thoroughly cover your hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Other information

Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed. Keep out of extreme temperatures.

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Lauramine Oxide, Dimethyltetradecylamine Oxide, DMDM Hydantoin (preservative), Fragrance*
*may contain this ingredient

KILLS 99.9% OF GERMS

ALCOHOL FREE

FRESH ALOE SCENT

NON-FLAMMABLE

DYE FREE

NON-IRRITATING

MOISTURIZING FORMULA

NO STING

Long Lasting, Kills 99.9% of Germs for Up to 4 Hours

Outlasts Alcohol-Based Sanitizers by Persisting on Skin

Alcohol Free Formula Won't Dry Hands, Sting, or Cause Cracking

Leaves Skin Feeling Nourished and Moisturized

Paraben-Free, Sulfate-Free, Phthalate-Free

Foaming Formula

Packaging

IMAGEIMAGEIMAGE

4 HOUR POWER HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77042-440
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77042-440-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
2NDC:77042-440-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
3NDC:77042-440-013785 mL in 1 JUG; Type 0: Not a Combination Product04/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/05/2021
Labeler - Guide Energy Solutions LLC (117045830)
Establishment
NameAddressID/FEIBusiness Operations
Guide Energy Solutions LLC117045830manufacture(77042-440) , pack(77042-440)

Revised: 4/2021
Document Id: 501a25ea-329f-49a5-ab22-c552a1fd047b
Set id: 1c2bc418-3149-4f0b-a3b8-fd1649263011
Version: 1
Effective Time: 20210406
 
Guide Energy Solutions LLC